Ethical software design and the associated services are based on a hardware/software and organizational structure that ensures compliance with the ISO/IEC 27001 Information Security Management System (ISMS) requirements and security controls. Ethical's parent company GM Servizi is yearly audited by an authorized ISO 27001Certification Authority.
Ethical’s software, systems, and services for Clinical Committee Management comply with all regulations that apply to EA: GxP, GAMP 5, US 21 CFR Part 11, EU GMP Vol. 4 Annex 11. Ethical provides, as an integrated component of our Services, the full GAMP 5 validation documentation package and support.
Ethical GmbH is committed to ensuring the security and protection of the personal information and to provide a compliant and consistent approach to data protection. We have a robust and effective data protection program in place which complies with European Union General Data Protection Regulation (EU-GDPR)
eAdjudication
software solution
service description
In order to shed light on endpoint adjudication, the LinkedIn Endpoint Adjudication Community generated an Events Charter Template for endpoint adjudication to assist those in need of guidance.
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Uppsala Clinical Research Center (UCR), a top Academic Research Organization based in Sweden, shares its experience in using eAdjudication platform to manage the central assessment of Clinical Trial Endpoints (CEC).
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Are you planning to submit Endpoint Adjudication Data to the FDA or the EMA? Submitted material are not only essential for obtaining marketing authorization but also a reflection of the quality of your company’s work.
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